Prophylaxis of Influenza
Conditions
Keywords
Influenza, Vaccine, CHMP criteria
Brief summary
Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.
Detailed description
An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.
Interventions
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Sponsors
Abbott Biologicals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. 3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.
Exclusion criteria
1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. 2. A serious adverse reaction after a previous (influenza) vaccination. 3. Presence of any significant condition that may prohibit inclusion as determined by the investigator. 4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period. 5. Having any condition which suppresses the immune system and autoimmune disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase | 3 weeks | Standard parameters to quantify antibody levels. Recommended in the CHMP guideline. |
| Solicited local and systemic reactions, overall inconvenience | 3 days | Reactogenicity and inconvenience |
| Unsolicited adverse events | 3 weeks | Other adverse events |
Countries
Germany
Outcome results
None listed